Regulatory Affairs Specialist II (Wound Closure & Healing) - Ethicon, Inc.
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DescriptionEthicon, Inc., part of Johnson & Johnson MedTech, is currently recruiting for a Regulatory Affairs Specialist II to support our Wound Closure & Healing business. The preferred location for this role is within a commutable distance of Raritan, NJ however remote options within the United States will be considered on a case-by-case basis. About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at The Regulatory Affairs Specialist II provides regulatory guidance to project teams in strategic planning and related submissions to support Ethicon Wound Closure & Healing (WCH) products. Under minimal supervision, the individual develops and executes regulatory strategy for significant change supplements and 510(k) registrations to support continued commercialization of products in key countries. The Specialist II helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures and systems.DUTIES & RESPONSIBILITIES:· Ensures compliance with regulatory agency regulations and interpretations.· Prepares responses to regulatory agencies' questions and other correspondence.· Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.· Provides solutions to a variety of problems of moderate scope and complexity.· Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.· Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance.· Provides regulatory guidance to project teams and responds to product information requests.· Provide Regulatory Affairs support during internal and external audits.· Assists in the development of best practices for Regulatory Affairs processes.· Represents Regulatory Affairs on cross-functional project teams.· Responsible for communicating business related issues or opportunities to next management level.· For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.· Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.· Performs other duties assigned as needed.The base pay range for this position is $75,000 to $105,000 based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.QualificationsEXPERIENCE AND EDUCATION· Minimum of a Bachelor's Degree required, Advanced Degree strongly preferred. Desired fields of study include sciences, biomedical engineering, medical/scientific writing, or public health administration.· At least 3+ years of relevant regulatory affairs experience within the healthcare industry required; MedTech and/or Pharma experience strongly preferred.· Knowledge of US (FDA) and OUS (EU Notified Bodies) health products regulations highly desired.· Previous medical device submission experience is strongly preferred.· Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes is desirable.· Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides regulatory assessments for product recall strategies).· Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives. · Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions. · Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.· Up to 20% travel may be required.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .Job Field: Regulatory AffairsOrganization: Ethicon Inc. (6045)